Reaction mass of Disodium decyl(sulphonatophenoxy)benzenesulphonate and Disodium oxybis[decylbenzenesulphonate]

Endpoint summary

Description of key information

Three in vivo studies on skin irritation on the registered substance are available that are supported by data from two other category members.

Six in vivo eye irritation studies on the registered substance, and one in vitro study on a category member are available. Additional in vivo eye irritation studies are available on other category members.

The ADPODS category members differ in structure and length of their alkyl side chains (refer to full read-across ADPODS category justification document). These structural differences do not affect/change the overall irritation potential for any of the category members including the registered substance, as demonstrated by the consistency in eye and skin testing outcomes and classifications.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was not conducted according to guideline/s and GLP but the report contains sufficient data for interpretation of study results.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

no guideline followed

Principles of method if other than guideline:

The skin irritation test included topical application of the material to intact and abraded skin on the abdomen of two male New Zealand White
rabbits. Both application sites on one rabbit were moistened with 0.5 ml of water, while the material was applied under dry conditions on the
other rabbit. The rabbits received either three (abraded sites) or five (intact sites) daily 0.5 g applications. The animals were on study for
eight days.

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Two male rabbits were used for the skin irritation test.

Type of coverage:

semiocclusive

Preparation of test site:

other: intact and abraded

Vehicle:

other: unchanged and moistened

Controls:

no

Amount / concentration applied:

0.5 g,
Both application sites on one rabbit were moistened with 0.5 ml of water, while the material was applied under dry conditions on the
other rabbit.

Duration of treatment / exposure:

The rabbits received either three (abraded sites) or five (intact sites) daily 0.5 g applications. The test material was left in place for 24 hours.

Observation period:

8 days

Number of animals:

2

Details on study design:

The skin irritation test included topical application of the material to intact and abraded skin on the abdomen of two male New Zealand White
rabbits. Both application sites on one rabbit were moistened with 0.5 ml of water, while the material was applied under dry conditions on the
other rabbit. The rabbits received either three (abraded sites) or five (intact sites) daily 0.5 g applications. The test material was applied under a cotton pad and held in place with a cloth bandage. The test material was left in place for 24 hours. The animals were on study for eight days.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24, 48, 72, 96 hours and 8 days

Score:

1

Max. score:

6

Reversibility:

other: not applicable

Remarks on result:

other: Intact abdomen- dry patch

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24, 48, 72 and 96 h and 8 days

Score:

1

Max. score:

6

Reversibility:

other: not applicable

Remarks on result:

other: Intact abdomen- dry patch

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24 h

Score:

3

Max. score:

6

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: Abraded abdomen- dry patch; Cotton glued on skin, erythema may be due to mechanical injury.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 48 and 72 h

Score:

4

Max. score:

6

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: Abraded abdomen- dry patch

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 96 h

Score:

3

Max. score:

6

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: Abraded abdomen- dry patch

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 8 days

Score:

1

Max. score:

6

Reversibility:

other: not applicable

Remarks on result:

other: Abraded abdomen- dry patch

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24, 48, 72 and 96 h and 8 days

Score:

1

Max. score:

6

Reversibility:

other: not applicable

Remarks on result:

other: Abraded abdomen- dry patch

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24 h

Score:

3

Max. score:

6

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: Intact abdomen- wet patch; Cotton glued on skin, erythema may be due to mechanical injury.

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 48 h

Score:

4

Max. score:

6

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: Intact abdomen- wet patch; Cotton glued on skin, erythema may be due to mechanical injury.

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 72 and 96 h

Score:

3

Max. score:

6

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: Intact abdomen- wet patch; Cotton glued on skin, erythema may be due to mechanical injury.

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 8 days

Score:

1

Max. score:

6

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24, 48, 72, and 96 h and 8 days

Score:

1

Max. score:

6

Reversibility:

other: not applicable

Remarks on result:

other: Intact abdomen- wet patch

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24 h

Score:

3

Max. score:

6

Reversibility:

fully reversible within: 96 h

Remarks on result:

other: Abraded abdomen- wet patch; Cotton glued on skin, erythema may be due to mechanical injury.

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 48 h

Score:

4

Max. score:

6

Reversibility:

fully reversible within: 96 h

Remarks on result:

other: Abraded abdomen- wet patch; Cotton glued on skin, erythema may be due to mechanical injury.

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 72 h

Score:

3

Max. score:

6

Reversibility:

fully reversible within: 96 h

Remarks on result:

other: Abraded abdomen- wet patch; Cotton glued on skin, erythema may be due to mechanical injury.

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 96 h and 8 days

Score:

1

Max. score:

6

Reversibility:

other: not applicable

Remarks on result:

other: Abraded abdomen- wet patch

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24, 48, 72 and 96 h and 8 days

Score:

1

Max. score:

6

Reversibility:

other: not applicable

Remarks on result:

other: Abraded abdomen- wet patch

Irritant / corrosive response data:

No irritation was observed when the test material was administered unmoistened (dry patch) to intact skin after prolonged and repeated contact. Slight to moderate erythema was observed after prolonged and repeated contact under moistened conditions (wet patch) and on the abraded site under unmoistened (dry patch)conditions. The dermal response was attributed to mechanical injury. The test material appeared to glue the cotton patch to the skin when moisture was present and removal of the patch was difficult. Results of the skin irritation test indicated the test material is unlikely to be absorbed in acutely toxic amounts.

Other effects:

None

None

Interpretation of results:

other: Not categorized, irritation was a result of mechanical injury

Remarks:

Criteria used for interpretation of results: other: EU GHS

Conclusions:

No irritation was observed when the test material was administered unmoistened (dry patch) to intact skin after prolonged and repeated contact. Slight to moderate erythema was observed after prolonged and repeated contact under moistened conditions (wet patch) and on the abraded site under unmoistened (dry patch)conditions. The dermal response was attributed to mechanical injury. The test material appeared to glue the cotton patch to the skin when moisture was present and removal of the patch was difficult. Results of the skin irritation test indicated the test material is unlikely to be absorbed in acutely toxic amounts.

Executive summary:

The test material, XU-40340.00 DOWFAX 3B2, powder form, was submitted by the Specialty Chemicals Technical Services & Development Department, The Dow Chemical Company, Midland, MI. The material is of interest for use in the agriculture, cleaning, and textile industries. Standard acute toxicologic tests were conducted and included the acute oral toxicity, skin irritation, and eye irritation studies.

Topical application of the test material to the skin of a New Zealand White rabbit, under dry conditions, resulted in no irritation after prolonged and repeated contact. Slight to moderate- erythema was observed under moistened conditions after prolonged and repeated contact. The dermal response was attributed to mechanical injury. The test material appeared to glue the cotton patch to the skin when moisture was present and removal of the patch was difficult.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was not conducted according to guideline/s and GLP but the report contains sufficient data for interpretation of study results.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

no guideline followed

Principles of method if other than guideline:

The eye irritation test included instillation of an aliquot of 0.1 g of the test material into each conjunctival sac of a male New.Zealand White rabbit. The right eye was washed for two minutes with tap water after a 30-second exposure. The left eye was not washed immediately after exposure. At various time intervals both eyes were examined for conjunctival irritation, corneal injury and irritation of the iris.

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Male New Zealand White rabbit

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5g

Duration of treatment / exposure:

Washed eye- 30 second exposure
Unwashed eye

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

1

Details on study design:

The eyes of the rabbit were established as being without defects or irritation 24 hours prior to study initiation. The eye irritation test included instillation of an aliquot of 0.1 g of the test material into each conjunctival sac of a male New Zealand White rabbit. The right eye was washed for two minutes with tap water after a 30-second exposure. The left eye was not washed immediately after exposure. At various time intervals both eyes were examined for conjunctival irritation, corneal injury and irritation of the iris. The eyes were anesthetized if moderate pain eas observed or anticipated. A drop of 5% aqueous fluorescein stain was used to aid in assessing corneal injury.

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 1, 24, 48, and 72 h and 7, 14 and 21 days

Score:

4

Max. score:

6

Reversibility:

not reversible

Remarks on result:

other: eye- not washed

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 1, 24, 48 and 72 h and 7 days

Score:

4

Max. score:

6

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: eye- not washed and after stain

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 14 and 21 days

Score:

3

Max. score:

6

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: eye- not washed and after stain

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 1 h

Score:

3

Max. score:

6

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: eye- not washed

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24 and 48 h

Score:

4

Max. score:

6

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: eye- not washed

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 72 h, 7, 14 and 21 days

Score:

3

Max. score:

6

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: eye- not washed

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 1 h

Score:

3

Max. score:

6

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: eye- washed

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24, 48, and 72 h and 7 and 14 days

Score:

4

Max. score:

6

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: eye- washed

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 21 days

Score:

3

Max. score:

6

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: eye- washed

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 1, 24, 48, and 72 h and 7 days

Score:

4

Max. score:

6

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: eye- washed and after stain

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 14 days

Score:

3

Max. score:

6

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: eye- washed and after stain

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 21 days

Score:

2

Max. score:

6

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: eye- washed and after stain

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 1 h

Score:

2

Max. score:

6

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: eye- washed

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24, 48 and 72 h and 7 days

Score:

3

Max. score:

6

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: eye- washed

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 14 and 21 days

Score:

2

Max. score:

6

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: eye- washed

Irritant / corrosive response data:

The eye irritation test included instillation of an aliquot of 0.1 g of the test material into each conjunctival sac of a male New.Zealand White rabbit. The single exposure resulted in moderate discomfort, moderate conjunctival redness and swelling, moderate reddening of the iris, and moderate corneal injury. Ocular effects were still present in both eyes at day 21 of the test and included slight to moderate conjunctival irritation, slight corneal injury, and slight reddening of the iris. Ophthalmic anesthetic was administered to alleviate discomfort experienced by the rabbit.

Other effects:

None

None

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Remarks:

Not reversible

Conclusions:

A single exposure of New Zealand White rabbit eyes to the test material resulted in moderate discomfort, moderate conjunctival redness and swelling , moderate reddening of the iris, and moderate corneal injury. Ocular effects were still present in both eyes at day 21 of the test and included slight to moderate conjunctival irritation, slight corneal injury, and slight reddening of the iris. Ophthalmic anesthetic was administered to alleviate discomfort experienced by the rabbit.

Executive summary:

The test material, XU-40340.00 DOWFAX 3B2 powder form, was submitted by the Specialty Chemicals Technical Services & Development Department, The Dow Chemical Company, Midland, MI. The material is of interest for use in the agriculture, cleaning, and textile industries. Standard acute toxicologic tests were conducted and included the acute oral toxicity, skin irritation, and eye irritation studies.

A single exposure of New Zealand White rabbit eyes to the test material resulted in moderate discomfort, moderate conjunctival redness and swelling , moderate reddening of the iris, and moderate corneal injury. Ocular effects were still present in both eyes at day 21 of the test and included slight to moderate conjunctival irritation, slight corneal injury, and slight reddening of the iris. Ophthalmic anesthetic was administered to alleviate discomfort experienced by the rabbit.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation:

This substance has been tested in three in vivo skin irritation assays. The key study for this endpoint is the assay demonstrated minimal irritation, but not sufficient to warrant classification. Similar (minimal) irritation potential was seen with the other ADPODS category members tested for skin irritation.

Eye irritation:

The available data indicate that this substance is capable of causing irreversible damage to the eyes. These same effects are seen with the other ADPODS category members tested for eye irritation/corrosion.

Justification for selection of skin irritation / corrosion endpoint:
acceptable study for the REACH-registered substance.

Justification for selection of eye irritation endpoint:
OECD Guideline, GLP study for the REACH-registered substance.

Effects on eye irritation: Irreversible damage

Justification for classification or non-classification

No classification is required for skin irritation for Reaction mass of Disodium decyl(sulphonatophenoxy)benzenesulphonate and Disodium oxybis[decylbenzenesulphonate]. For eye irritation, classification for irreversible damage to the eyes is applied (Category 1, according to CLP).